Bjork-Shiley Cardiac Valve

No FDA recalls on record, checked 22 Oct 2026.

Generic Name

HEART-VALVE, MECHANICAL

PMA Number

P780008 ↗

FDA Product Code

LWQ

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

PMA Supplement

S013

• Stockert-Shiley Caps Venous Occlusion Clamp

  Class I

  FDA 510(k) K864890 Active Cleared 19 Feb 1987

• Basic Heater-Cooler Unit, 115/100V 16-02-20

  Class II

  FDA 510(k) K883330 Active Cleared 26 Sep 1988

• Schneider-Shiley Y-Connector with Rotator

  Class II

  FDA 510(k) K862464 Active Cleared 28 Aug 1986

• Expanded Use for Shiley 3l Cardiotomy Reservoir

  Class II

  FDA 510(k) K872721 Active Cleared 23 Sep 1987

• Shiley Venous Reservoir

  Class II

  FDA 510(k) K854841 Active Cleared 10 Feb 1986

• Arterial Embolectomy Catheter

  Class II

  FDA 510(k) K840198 Active Cleared 3 Aug 1984

See all devices from Shiley, Inc. →

• What type of device is the Bjork-Shiley Cardiac Valve?

  The Bjork-Shiley Cardiac Valve is classified as a mechanical heart valve implant, as defined by its generic name and device type in the specifications, which identify it as a HEART-VALVE, MECHANICAL for cardiovascular use.

• Who manufactures the Bjork-Shiley Cardiac Valve?

  The Bjork-Shiley Cardiac Valve is manufactured by Shiley, Inc., as explicitly stated in the MANUFACTURER and applicant fields of the device data.

• What regulatory authorization does the Bjork-Shiley Cardiac Valve have?

  The device has received FDA Premarket Approval (PMA) under number P780008, as indicated by the AUTHORIZATIONS field showing FDA_PMA and the pma_number field specifying P780008 with a decision date of 1982-02-05 and decision code APPR.